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SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)

NCT03806452 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-05-14

Study results available
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Summary

The purpose of this phase IIb, international, multicentre, double-blind, randomised, placebo-controlled study is to determine the effect of hydroxycarbamide on albuminuria after 6 months of treatment in SCD adult patients.

Conditions

Interventions

DRUG

Hydroxycarbamide

Hydroxycarbamide tablets of 100 and 1000 mg

DRUG

Placebo Oral Tablet

Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets

Sponsors & Collaborators

  • Theravia

    lead INDUSTRY

Principal Investigators

  • Pablo Bartolucci, Pr · Henri Mondor University Hospital

  • Vincent Audard, Pr · Henri Mondor University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-28
Primary Completion
2024-05-30
Completion
2024-05-30

Countries

  • Côte d’Ivoire
  • France
  • Guadeloupe
  • Mali
  • Martinique
  • Senegal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806452 on ClinicalTrials.gov